MHRA clarifies licencing route for microbiome-based medicines

The MHRA has clarified its position on the UK licencing route for microbiome-based medicines.

(c) CDC/Unsplash

(c) CDC/Unsplash

position paper has outlined how microbiome-based medicines can be made available for patients in the UK. 

Julian Beach, executive director of Healthcare Quality and Access at the MHRA, said: ‘Microbiome-based medicinal products represent one of the most interesting and fast-moving areas in medicine today. Our position paper gives developers the clarity they need to bring these innovations forward with confidence, while ensuring patients continue to be protected by the same rigorous standards that underpin all licensed medicines in the UK.'

Microbiome-based medicinal products are medicines that work through modulating, restoring or replacing the human microbiome. They represent a promising new category of therapies with the potential to address areas of significant unmet clinical need such as antimicrobial resistance. 

The MHRA's position is that MBMPs fall within the scope of the existing UK medicines regulatory framework, set out in the Human Medicines Regulations 2012.

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